Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of Sintilimab injection combined with Inlyta in fumarate hydratase-deficient renal cell carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West China Hospital
• Treatments: Axitinib

Criteria

Inclusion Criteria:

1. age ≥ 18;

2. histology characteristics accord with FH-deficient RCC;

3. gene testing confirms germline and/or somatic FH gene mutation ;

4. ECOG (Eastern Cooperative Oncology Group)≤2;

5. expected survival >3 months;

6. blood routine indexes: neutrophils ≥1.5*109, platelets ≥100*109, hemoglobin ≥90g/L;

7. liver function: bilirubin ≤ normal upper limit 1.5 times, AST≤ normal upper limit 2.5 times;Serum creatinine ≤ 1.5 times of normal upper limit;Serum calcium concentration: ≤12.0 mg/dL;

8. coagulation function: PT≤ 1.5 times of normal upper limit;

9. the following diseases did not appear within 12 months: myocardial infarction, severe or unstable angina pectoris, asymptomatic heart failure, cardiovascular and cerebrovascular accident or transient ischemic attack, etc.

10. all patients signed informed consent.

Exclusion Criteria:

1. other malignancies previously or at the same time that are different from the primary site or histology of the tumor assessed in this study, except cervical carcinoma in situ, basal-cell carcinoma that has been fully treated, superficial bladder tumor (Ta, Tis, T1) or other malignancies that occurred before the enrollment and have been cured for more than 3 years;

2. renal decompensation requires hemodialysis or peritoneal dialysis;

3. arrhythmia need anti-arrhythmic treatment, symptomatic coronary artery disease or myocardial ischemia (myocardial infarction), nearly six months, or congestive heart failure than NYHA Ⅱ level; Hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) that has been treated with 2 or more antihypertensive treatments and still cannot be controlled;

4. severe active clinical infection;

5. patients with coagulation disorder or bleeding constitution;

6. major surgery or severe trauma was performed within 4 weeks before enrollment;

7. a history of allogeneic organ transplantation or bone marrow transplantation;

8. drug abuse and medical, psychological or social conditions that may interfere with patients' participation in research or affect the evaluation of results;

9. known or suspected allergy to the study drug;

10. those who received treatment other than this study within 4 weeks prior to and during the study period.